The FDA and AstraZeneca are going beyond the label with cancer drugs—literally. In a new pilot program, the FDA will publish patient-reported symptoms that are collected during clinical trials but typically go undisclosed.
AstraZeneca is the first, and so far only, drugmaker in the program, and it's starting with expanded patient details from its late-stage AURA3 trial that compared Tagrisso to platinum-based chemotherapy.
The additional information includes 28 different symptoms that patients reported during the trial, ranging from dry mouth and itchy skin to shaking chills and hair loss. The disclosure lists the percentage of patients on each regimen who experienced a given symptom.
AstraZeneca got involved with the Project Patient Voice project when the FDA reached out to ask if it would share data collected from patients during its AURA3 clinical trial. AZ was the first pharma to use the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The survey is meant to specifically record patients' symptoms during oncology clinical trials. Drug companies already use the CTCAE questionnaire for physicians to record adverse events in oncology trials. AZ and the FDA have been working on the pilot for about a year.
“We have heard from patients throughout our work that many of them do wish they had access to this type of information to inform their decisions and have better conversations with their doctor, but also, importantly, to know what to expect from the treatment,” Katarina Halling, AZ’s head of Patient Centered Science, said.
The FDA said its goal is to get more information into the hands of physicians and patients to help make decisions about cancer treatments. The unpublished data can't be included in an official product label for lack of space or other reasons, the agency said.
“The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development. Where patient-reported symptom information is collected rigorously, this information should be readily available to patients,” Amy Abernathy, the FDA’s Principal Deputy Commissioner, said in a news release.
While AstraZeneca is the only drugmaker in the pilot, the FDA said it hopes to expand the program to include more cancer drug trials. Eventually, the Project Patient Voice website will include each cancer trial with patient symptom data ranging from a baseline before treatment through six months of treatment.
An FDA virtual workshop, co-sponsored by the American Society of Clinical Oncology, is set for July 17 to gather feedback on the program from healthcare providers, patients, industry and advocacy groups and others who attend.
Editor's note: This story was updated with comments from AstraZeneca.